| Bibliografía
- NMX-CC-9001-IMNC-2015, Sistemas de gestión de la calidad-Requisitos. Declaratoria de vigencia publicada en el Diario Oficial de la Federación el 3 de mayo de 2016. - NMX-CC-10012-IMNC-2004, Sistemas de gestión de las mediciones-Requisitos para los procesos de medición y los equipos de medición. Declaratoria de vigencia publicada en el Diario Oficial de la Federación el 27 de julio de 2004. - ISO 11607:2006, Packaging for terminally sterilized medical devicesâPart. 1: Requirements for materials, sterile barrier systems and packaging systems. Ed.1, (2006 abril) - ISO 11607-2:2006, Packaging for terminally sterilized medical devicesâPart 2: Validation requirements for forming, sealing and assembly process. Ed.1, (2006 abril) - ISO 14644-1:2015, Cleanrooms and associated controlled environments--Part 1: Classification of air cleanliness by particle concentration Ed. 2, (2015 diciembre) - ISO 14644-2:2015, Cleanrooms and associated controlled environments--Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration Ed. 2, (2015 diciembre) - ISO 14644-3:2005, Cleanrooms and associated controlled environments--Part 3: Test methods Ed. 1, (2005 diciembre) - ISO 14644-4:2001, Cleanrooms and associated controlled environments--Part 4: Design, construction and start-up Ed.1, (2001 abril) - ISO 14644-5:2004, Cleanrooms and associated controlled environments--Part 5: Operations Ed. 1, (2004 agosto) - ISO 14644-7:2004, Cleanrooms and associated controlled environments--Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) Ed.1, (2004 octubre) - ISO 14644-8:2013, Cleanrooms and associated controlled environments--Part 8: Classification of air cleanliness by chemical concentration (ACC) Ed. 2, (2013 febrero) - ISO 14644-9:2012, Cleanrooms and associated controlled environments--Part 9: Classification of surface cleanliness by particle concentration Ed. 1, (2012 agosto) - ISO 14644-10:2013, Cleanrooms and associated controlled environments--Part 10: Classification of surface cleanliness by chemical concentration Ed. 1, (2013 marzo) - ISO 14644-13:2017, Cleanrooms and associated controlled environments--Part 13: Cleaning of surfaces to achieve defined levels of cleanliness in terms of particle and chemical classifications Ed. 1, (2017 junio) - ISO 14644-14:2016, Cleanrooms and associated controlled environments--Part 14: Assessment of suitability for use of equipment by airborne particle concentration Ed. 1, (2016 septiembre) - ISO 14698-1:2003, Cleanrooms and associated controlled environments--Biocontamination control--Part 1: General principles and methods Ed. 1, (2003 septiembre) - ISO 14698-2:2003, Cleanrooms and associated controlled environments--Biocontamination control--Part 2: Evaluation and interpretation of biocontamination data Ed. 1, (2003 septiembre) - ISO 14698-2:2003/Cor 1:2004 Cleanrooms and associated controlled environments--Biocontamination control--Part 2: Evaluation and interpretation of biocontamination data Ed.1, (2004 noviembre) - ISO 14971:2007, Medical devicesâApplication of risk management to medical devices. Ed. 2, (2007 marzo) - NMX-CC-19011-IMNC-2012, Directrices para la auditoría de los sistemas de gestión. Declaratoria de vigencia publicada en el Diario Oficial de la Federación el 17 de septiembre de 2012. - IEC 62366-1:2015, Medical devicesâPart 1: Application of usability engineering to medical devices. Ed. 1, (2015 febrero) - GHTF/SG1/N055:2009, Definition of the Terms Manufacturer, Authorised Representative, Distributor and Importer - GHTF/SG5/N4:2009, Post-Market Clinical Follow-Up Studies - GHTF/SG1/N70:2011, Label and Instructions for Use for Medical Devices - GHTF/SG1/N071:2012, Definition of the Terms "Medical Device" and "In Vitro Diagnostic (IVD) Medical Device" - Farmacopea de los Estados Unidos Mexicanos (FEUM) 2017-1/"Dispositivos médicos"/Apéndice II | 
